Dental DiseasesNCT04492306
Clinical Evaluation of Dimethyl Sulfoxide Dentin Pre-treatment
A study testing Dimethyl Sulfoxide, 3M ESPE Single bond 2 and Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA) in people with Dental Diseases, run by Cairo University at 1 site in Egypt.
Trial summary
This study is conducted in order to evaluate the clinical effectiveness of 1% DMSO dentin pre-treatment on the clinical performance of etch and rinse adhesive. Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Dental Diseases
- What is being tested?
- Dimethyl Sulfoxide, 3M ESPE Single bond 2 and Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Nov 2020to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with cervical lesions.
- Co-operative patients approving to participate in the study.
- Pulp is asymptomatic vital teeth.
- Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.
Who cannot join
- Xerostomia.
- Bruxism and visible wear facets in the posterior dentition.
- Known inability to return for recall appointments.
- Fractured or visibly cracked candidate tooth.
- Current desensitizing therapy, including desensitizing dentifrices or other over-the-counter (OTC) products.
- Long-term use of anti-inflammatory, analgesic, or psychotropic drugs.
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- Pregnancy or breastfeeding (potential conflicts with recall dates.
- Allergies to ingredients of resin-based restorative materials.
- Orthodontic appliance treatment within the previous three months.
- Abutment teeth for fixed or removable prostheses.
- Teeth or supporting structures with any symptomatic pathology.
- Existing periodontal disease or periodontal surgery within the previous three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vivo Clinical Evaluation of Dimethyl Sulfoxide Dentin Pre-treatment Prior to a Two-step Etch and Rinse Adhesive: Randomized Controlled Trial
This study is conducted in order to evaluate the clinical effectiveness of 1% DMSO dentin pre-treatment on the clinical performance of etch and rinse adhesive.
Read the detailed description
Despite substantial advances in resin-dentin bonding over the past decades, reduction in bonding effectiveness of currently available dental adhesives remains a major limitation in modern adhesive dentistry. Hydrolysis of both organic and resin constituents of hybrid layer persists as impediments in dentin bonding longevity. Since bonding is directly related to the quality of the formed polymer the resin components play an important role in proper resin-dentin interaction and in the mechanical properties of the material.
In face of the limitations of most current clinically-feasible bonding protocols and inherent drawbacks of the etch-and-rinse approach an ideal resin-enveloped collagen scaffold is unlikely to be produced in a consistent manner. In dentin hybridization, adhesive infiltration is far from perfect resulting in poorly formed hybrid layers. Replacement of all 70 vol% residual water in etched-dentin with monomers is hardly achieved. For this reason, the hybrid layer may be considered as the weak link in resin-dentin bonds.
DMSO [(CH3)2SO] is a polar aprotic solvent that dissolves both polar and non-polar compounds. It is a polyfunctional molecule, with a highly polar S O group and two hydrophobic methyl groups, fully miscible in most solvents and monomers used in adhesive dentistry. DMSO is perhaps the best currently known penetration enhancer for medical purposes with the ability to dissociate the highly crosslinked collagen into a sparser network of apparent fibrils.
The rationale for testing a bonding resin with relatively low DMSO-content is that incorporation of high DMSO concentrations may hamper the mechanical properties of dimethacrylate bonding polymers, which in turn could compromise the bonded interface. DMSO's ability to "biomodify" collagen structure, increasing spaces between collagen microfibrils and improving dentin wettability support the improved bonding effectiveness even under dry-conditions. It is evident that this simplified use of DMSO or, to a better extent, its use as a dentin pretreatment reduced technique sensitivity of the etch-and-rinse approach concomitantly allowing water removal from the bonded interface by the proposed dry-bonding technique. Optimized bonding efficiency combined with reduced water-content during dentin hybridization could greatly contribute to clinical long-term durability.
Nevertheless, further studies are necessary to test such hypothesis. Specially that there is no clinical study support this theory yet even DMSO had taken the FDA approval many years ago as a pharmaceutical solvent and has been used in several medications. DMSO caused no or minor cytotoxic effects on the pulp tissue repair-related activity of odontoblast-like cells.
- Conditions
- Dental Diseases
- Being tested
- Dimethyl Sulfoxide, 3M ESPE Single bond 2, Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA), 3m ESPE etch
- Keywords
- DMSO
- Medical subject headings
- Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dimethyl SulfoxideOther
Also called 1% DMSO
DMSO [(CH3)2SO] is a polar aprotic solvent that dissolves both polar and non-polar compounds.
3M ESPE Single bond 2Other
Total etch adhesive bond
Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA)Other
Composite Resin
3m ESPE etchOther
32% phosphoric acid
| Study group | Role | What they receive |
|---|---|---|
| 3M single bond, etch and rinse adhesive | Active comparator | O.I. will clean the labial surface of tooth with polishing paste and brush Roughening of the surface may be needed by diamond point The tooth will be isolated by rubber dam. Apply etchant for 30 s for enamel and 15 s for dentin. Rinse thoroughly with water for 10 s. blot-drying with paper tissue was carefully performed leaving the dentin surface slightly moist.
Apply 2 to 3 consecutive coats of the adhesive for 15 s. Gently air for 5 s. Light cure for 10 s. Composite build ups (Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA) were performed in increments and individually light-cured for 40 s. Light curing of all resin materials was performed using a LED device (Bluephase 20i, Ivoclare Vivadent, Schaan, Liechtenstein) delivering 1100 mW/cm2. Receives: Other: 3M ESPE Single bond 2; Other: Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA); Other: 3m ESPE etch |
| DMSO pre-treatment before 3M single bond application | Experimental | The same steps of the comparator group with additional step, after dentin etching and humidity control, dentin pretreatments were performed consisting of active application of 1% DMSO/H2O solutions on etched-dentin followed by blot drying until paper filters no longer absorbed liquids from the bonding surface by capillarity then apply adhesive. Receives: Other: Dimethyl Sulfoxide; Other: 3M ESPE Single bond 2; Other: Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA); Other: 3m ESPE etch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological (change of caries adjacent to the restoration)
FDI criteria for evaluation of restorations, percentage score.
- Score: Properties
- Clinically excellent/ very good: No secondary or primary caries.
- Clinically good: Small and Localized 1. Demineralization, 2. Erosion or 3. Abfraction.
- Clinically sufficient/satisfactory: Larger areas Of 1. Demineralization, 2. Erosion or 3. Abrasion/abfraction, dentine not exposed.
- Clinically unsatisfactory: Caries with Cavitation and suspected undermining caries, 2. Erosion in dentine, 3. Abrasion/ abfraction in dentine.
- Clinically poor: Deep caries or exposed dentine that is not accessible for repair of restoration.
Measured: Day 0, Month 6, Month 12, Month 18
Secondary outcomes (1)
Functional (change of marginal adaptation)
FDI criteria for evaluation of restorations, percentage score.
- Score: Properties.
- Clinically excellent/ very good: Harmonious outline, no gaps, no white or discolored lines.
- Clinically good: Marginal gap (<150 µm), White lines. Or Small marginal fracture removable by polishing. or Slight ditching, slight step/flashes, minor Irregularities.
- Clinically sufficient/satisf actory: Gap < 250 µm not removable. Or Several small marginal fractures. Or Major irregularities, ditching or flash, steps.
- Clinically unsatisfactory: Gap > 250 µm or dentine/base exposed. Or Severe ditching or marginal fractures. or Larger irregularities or steps (repair necessary).
- Clinically poor: Restoration (complete or partial) is loose but in situ. Or Generalized major gaps or irregularities.
Measured: Day 0, Month 6, Month 12, Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start17 Nov 2020
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental DiseasesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turku
- Responsible party
- Principal investigator, Omar Abdelaziz Ismail, Cairo University
- Investigators
- Randa Hafez, Professor, Study director, Cairo U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492306
- Sponsor's protocol ID
- DMSO Clinical Trial
- Status last verified
- Feb 2023
- First submitted
- 22 Jul 2020
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Clinical Evaluation of Dimethyl Sulfoxide Dentin Pre-treatment Prior to a Two-step Etch and Rinse Adhesive: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04492306
- Acronym / sponsor ID
- DMSO Clinical Trial
- Conditions
- Dental Diseases
- Keywords
- DMSO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- University of Turku
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is conducted in order to evaluate the clinical effectiveness of 1% DMSO dentin pre-treatment on the clinical performance of etch and rinse adhesive.
Detailed description
Despite substantial advances in resin-dentin bonding over the past decades, reduction in bonding effectiveness of currently available dental adhesives remains a major limitation in modern adhesive dentistry. Hydrolysis of both organic and resin constituents of hybrid layer persists as impediments in dentin bonding longevity. Since bonding is directly related to the quality of the formed polymer the resin components play an important role in proper resin-dentin interaction and in the mechanical properties of the material.
In face of the limitations of most current clinically-feasible bonding protocols and inherent drawbacks of the etch-and-rinse approach an ideal resin-enveloped collagen scaffold is unlikely to be produced in a consistent manner. In dentin hybridization, adhesive infiltration is far from perfect resulting in poorly formed hybrid layers. Replacement of all 70 vol% residual water in etched-dentin with monomers is hardly achieved. For this reason, the hybrid layer may be considered as the weak link in resin-dentin bonds.
DMSO [(CH3)2SO] is a polar aprotic solvent that dissolves both polar and non-polar compounds. It is a polyfunctional molecule, with a highly polar S O group and two hydrophobic methyl groups, fully miscible in most solvents and monomers used in adhesive dentistry. DMSO is perhaps the best currently known penetration enhancer for medical purposes with the ability to dissociate the highly crosslinked collagen into a sparser network of apparent fibrils.
The rationale for testing a bonding resin with relatively low DMSO-content is that incorporation of high DMSO concentrations may hamper the mechanical properties of dimethacrylate bonding polymers, which in turn could compromise the bonded interface. DMSO's ability to "biomodify" collagen structure, increasing spaces between collagen microfibrils and improving dentin wettability support the improved bonding effectiveness even under dry-conditions. It is evident that this simplified use of DMSO or, to a better extent, its use as a dentin pretreatment reduced technique sensitivity of the etch-and-rinse approach concomitantly allowing water removal from the bonded interface by the proposed dry-bonding technique. Optimized bonding efficiency combined with reduced water-content during dentin hybridization could greatly contribute to clinical long-term durability.
Nevertheless, further studies are necessary to test such hypothesis. Specially that there is no clinical study support this theory yet even DMSO had taken the FDA approval many years ago as a pharmaceutical solvent and has been used in several medications. DMSO caused no or minor cytotoxic effects on the pulp tissue repair-related activity of odontoblast-like cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3M single bond, etch and rinse adhesive | Active comparator | Other: 3M ESPE Single bond 2, Other: Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA), Other: 3m ESPE etchO.I. will clean the labial surface of tooth with polishing paste and brush Roughening of the surface may be needed by diamond point The tooth will be isolated by rubber dam. Apply etchant for 30 s for enamel and 15 s for dentin. Rinse thoroughly with water for 10 s. blot-drying with paper tissue was carefully performed leaving the dentin surface slightly moist. Apply 2 to 3 consecutive coats of the adhesive for 15 s. Gently air for 5 s. Light cure for 10 s. Composite build ups (Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA) were performed in increments and individually light-cured for 40 s. Light curing of all resin materials was performed using a LED device (Bluephase 20i, Ivoclare Vivadent, Schaan, Liechtenstein) delivering 1100 mW/cm2. |
| DMSO pre-treatment before 3M single bond application | Experimental | Other: Dimethyl Sulfoxide, Other: 3M ESPE Single bond 2, Other: Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA), Other: 3m ESPE etchThe same steps of the comparator group with additional step, after dentin etching and humidity control, dentin pretreatments were performed consisting of active application of 1% DMSO/H2O solutions on etched-dentin followed by blot drying until paper filters no longer absorbed liquids from the bonding surface by capillarity then apply adhesive. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with cervical lesions.
- Co-operative patients approving to participate in the study.
- Pulp is asymptomatic vital teeth.
- Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.
Key exclusion criteria (12 listed)
- Xerostomia.
- Bruxism and visible wear facets in the posterior dentition.
- Known inability to return for recall appointments.
- Fractured or visibly cracked candidate tooth.
- Current desensitizing therapy, including desensitizing dentifrices or other over-the-counter (OTC) products.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dimethyl SulfoxideAlso: 1% DMSODMSO [(CH3)2SO] is a polar aprotic solvent that dissolves both polar and non-polar compounds. | Other | DMSO pre-treatment before 3M single bond application |
| 3M ESPE Single bond 2Total etch adhesive bond | Other | 3M single bond, etch and rinse adhesive, DMSO pre-treatment before 3M single bond application |
| Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA)Composite Resin | Other | 3M single bond, etch and rinse adhesive, DMSO pre-treatment before 3M single bond application |
| 3m ESPE etch32% phosphoric acid | Other | 3M single bond, etch and rinse adhesive, DMSO pre-treatment before 3M single bond application |
Primary outcome
Biological (change of caries adjacent to the restoration)
Time frame: Day 0, Month 6, Month 12, Month 18
FDI criteria for evaluation of restorations, percentage score. * Score: Properties * Clinically excellent/ very good: No secondary or primary caries. * Clinically good: Small and Localized 1. Demineralization, 2. Erosion or 3. Abfraction. * Clinically sufficient/satisfactory: Larger areas Of 1. Demineralization, 2. Erosion or 3. Abrasion/abfraction, dentine not exposed. * Clinically unsatisfactory: Caries with Cavitation and suspected undermining caries, 2. Erosion in dentine, 3. Abrasion/ abfraction in dentine. * Clinically poor: Deep caries or exposed dentine that is not accessible for repair of restoration.
1 secondary outcome
Functional (change of marginal adaptation)
Time frame: Day 0, Month 6, Month 12, Month 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randa Hafez, Professor study director
Cairo U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dimethyl Sulfoxide, 3M ESPE Single bond 2 and Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA) in people with Dental Diseases, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological (change of caries adjacent to the restoration) (time frame: Day 0, Month 6, Month 12, Month 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.